Method of overwrapping a pessary device

ABSTRACT

This application relates to a method of covering a pessary device for relief of female incontinence with an overwrap. More particularly, the present invention relates to methods of overwrapping the pessary device.

FIELD OF INVENTION

This application relates to a method of covering a pessary device forrelief of female incontinence with an overwrap. More particularly, thepresent invention relates to methods of overwrapping the pessary device.

BACKGROUND OF THE INVENTION

Urinary incontinence, in which the ordinary bodily muscle functions failto prevent unintended leakage of urine, is a common malady among women,particularly older women. It is estimated that up to 50% of womenoccasionally leak urine involuntarily, and that approximately 25% ofwomen will seek medical advice at some point in order to deal with theproblem. Stress incontinence, the most common type of urinaryincontinence, refers to the involuntary loss of urine resulting fromabdominal pressure rise, occurring during exercise, coughing, sneezing,laughing, etc. When stress incontinence occurs, it is usually the resultof the abnormal descent of the urethra and bladder neck below the levelof the pelvic floor. Many women wear sanitary napkins or diapers inorder to deal with incontinence, and some women resort to surgicalprocedures.

Pessary devices are known to help relieve involuntary urination in afemale. Such pessary devices can be uncomfortable for a user duringinsertion and/or removal. Depending on the surface properties of thematerial, the pessary device may require additional force to remove thepessary device.

As such, there remains a need for a pessary device with improved comfortduring use. One way to improve comfort is to wrap the device with anoverwrap which becomes the contact layer of the device with the body. Assuch, there remains a need for a method to overwrap the pessary deviceto increase comfort upon insertion, use, and removal.

Further, there remains a need for a pessary device with improved comfortduring the removal process.

SUMMARY OF THE INVENTION

A method of wrapping a pessary device is provided. The method includesproviding a pessary device having an outer wall, an interior, anexternal opening to the interior, and a longitudinal axis. The methodalso includes providing an overwrap having a longitudinal axis, whereinthe overwrap forms a hollow structure. The method further includesplacing at least a portion of the pessary device inside the overwraphollow structure, wherein the overwrap enrobes the pessary device andexceeds the pessary device along the longitudinal axis to create anoverwrap excess. The overwrap excess is positioned in the pessary deviceinterior to provide the wrapped pessary device.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims particularly pointing outand distinctly claiming the subject matter of the present invention, itis believed that the invention can be more readily understood from thefollowing description taken in connection with the accompanyingdrawings, in which:

FIG. 1 is a flowchart representation of the method.

FIG. 2A is a side view of a pessary device.

FIG. 2B is a perspective view of the pessary device of FIG. 2B.

FIG. 3 is a cross-section view of a pessary device.

FIG. 4 is a cross-section view of a pessary device.

FIG. 5 is a cross-section view of a pessary device.

FIG. 6 is a perspective view of a pessary device.

FIG. 7 is a side view of a pessary device.

FIG. 8 is a top view of a pessary device on an overwrap.

FIG. 9 is a perspective view of a pessary device inside an overwrap.

FIG. 10 is a perspective view of a pessary device inside an overwrap.

FIG. 11A-D show examples of external opening to the interior engagingmembers.

FIG. 12 is a side view of a pessary applicator, housing the pessary ofFIG. 2.

DETAILED DESCRIPTION OF THE INVENTION

As used herein, “applicator” refers to a device or implement thatfacilitates the insertion of the pessary device into an external orificeof a mammal. Exemplary applicators include telescoping, tube andplunger, and compact applicators.

As used herein, the term “enrobe” or “enrobing” refers to covering aportion of a surface of a pessary device with an overwrap. The portionof the surface of the pessary device covered with the overwrap is atleast equivalent to the area calculated by measuring the length of thepessary device along the longitudinal axis and multiplying that numberwith a perimeter calculation of the pessary device at its maximum areaalong the longitudinal axis.

The term “joined” or “attached” as used herein, encompassesconfigurations in which a first element is directly secured to a secondelement by affixing the first element directly to the second element,configurations in which the first element is indirectly secured to thesecond element by affixing the first element to intermediate member(s)which in turn are affixed to the second element, and configurations inwhich first element is integral with second element, i.e., first elementis essentially part of the second element.

As used herein, the term “non-expandable” refers to devices that do notexpand prior to or during use, such as, for example, devices that do notincrease in size or volume prior to or during use. For example,non-expandable devices have a diameter and/or volume that does notincrease. In contrast, “expandable” as used herein, refers to devicesthat do increase in size or volume prior to or during use, such as, forexample, devices that increase in diameter and/or length, absorb fluidinto a fibrous or absorbent gelling material structure, or otherwisechange from a first size or volume to a second size or volume, such as,for example, by inflation, absorption, mechanically, or by other means.Insubstantial changes to a non-expandable device as a result of anythermal expansion that could occur at body temperatures are notconsidered “expansion.”

A “pessary device” or more particularly an “incontinence pessary device”as used herein refers to devices specifically designed, configured,and/or adapted for placement into a vagina in order to reduce theoccurrence and/or severity of female urinary incontinence. A “pessarydevice” can include any type of substantially non-absorbent structurefor the purpose of reducing urine leakage and/or supporting a prolapseduterus and/or bladder. A pessary device does not include a menstrualtampon.

As used herein, the term “vaginal canal” refers to the internalgenitalia of the human female in the pudendal region of the body. Theterms “vaginal canal” or “within the vagina” as used herein are intendedto refer to the space located between the introitus of the vagina(sometimes referred to as the sphincter of the vagina) and the cervix.

The present invention is directed to a method of wrapping pessarydevices with an overwrap. The pessary device has an outer wall, aninterior, an external opening to the interior, and a longitudinal axis.The overwrap has a longitudinal axis, wherein the overwrap forms ahollow structure. At least a portion of the pessary device is placedinside the overwrap hollow structure, wherein the overwrap enrobes thepessary device and exceeds the pessary device along the longitudinalaxis to create an overwrap excess. The overwrap excess is positioned inthe pessary device interior.

The pessary device includes an upper portion, a lower portion, a middleportion, a pressure region of the upper portion, a pressure region ofthe lower portion, a maximum diameter, a minimum diameter, a slopeextending from the upper portion to the middle portion, a slope from themiddle portion to the lower portion, a longitudinal axis, and atransverse axis. The pessary device can be symmetric about thelongitudinal axis, including for example, wherein the base is circularand symmetric about the longitudinal axis. The pessary device can haveouter wall and an interior defined by inner walls that is hollow inregion. The hollow region can be provided at one or both ends. Inaddition, the pessary device can have a portion of the interior that issolid. The pessary device does not change in size during the usageexperience, that is, the pessary device is the same size and diameterprior to insertion by the user as well as during use and removal.

The pessary device can be a unitary construction. For example, thepessary device can include a continuous outer shell that defines theentire exterior surface of the pessary device. The outer shell can besmooth or textured. The outer shell may be permeable to fluid, such as,for example, by the inclusion of holes, pores, or other suitableexternal openings. Alternatively, the outer shell can be impermeable tofluid such that fluid cannot enter the device. In addition, the pessarydevice can include an external opening in the top and/or base. Thepessary device can include an external opening in the top and/or baseand the outer shell is not permeable to fluid such that fluid cannotenter the device except through the external opening in the top and/orbase. The external opening in the top and or base may have externalopening to the interior engaging members. The engaging members can betriangles, half circles, quarter circles, and/or geometric shapes withpoints. The engaging members can engage with the overwrap. Suitablepessary devices are typically smaller in size than conventional pessarydevices. For example, the pessary devices have a maximum diameter, alength, and/or a volume that is smaller or less than that ofconventional pessary devices.

The pessary device is covered by an overwrap. The overwrap can benon-absorbent or absorbent and can include any suitable material, suchas, for example, a fibrous nonwoven material comprising natural,synthetic, or a blend of natural and synthetic fibers. Suitablesynthetic fibers can include, e.g., fibers such as polyester,polyolefin, nylon, polypropylene, polyethylene, polyacrylic, celluloseacetate, polyhydroxyalkanoates, aliphatic ester polycondensates,bicomponent fibers and/or mixtures thereof. Natural fibers can include,e.g., rayon and those commonly known to be non-synthetic and of naturalorigin such as cotton. The fibers can have any suitable cross-sectionalshape, such as, e.g., round, tri-lobal, multi-lobal, delta, hollow,ribbon-shaped, and/or any other suitable shape, or mixtures thereof.Fibers with any suitable diameter can be used, such as, e.g., from about0.5 to about 50 microns, such as, e.g., from about 1 to about 30microns, such as, e.g., from about 10 to about 25 microns. Fiberdiameter can be determined using any suitable means; however, fornon-round fibers, diameter can typically be determined by reference tothe diameter of a fiber with the same cross-sectional area as thenon-round fiber.

The overwrap can be joined to the pessary device by any variety ofmeans. The overwrap can be joined to itself or to the pessary device.For example, one portion of overwrap can be joined to an opposed portionof the overwrap or to the pessary device using any suitable adhesive,heat, vacuum, air, pressure bonding, and/or mechanical means. Suchadhesive can extend continuously along the length of attachment or itcan be applied in a non-continuous fashion at discrete intervals. Heatbonding includes thermally bonding, fusion bonding, or any othersuitable means for joining such materials. The overwrap can be joined toitself to form a hollow structure. The hollow structure may be in theform of any multi-dimensional geometric structure such as, for example,a cylinder, tunnel, tube, cube, and/or a pyramid.

At least a portion of the pessary device may be placed inside theoverwrap hollow structure. The overwrap hollow structure may enrobe thepessary device. The overwrap can enrobe the pessary device by wrappingthe pessary device along the longitudinal axis of the pessary device.The overwrap may enrobe the pessary device by rolling the pessary devicealong the longitudinal axis when placed inside the overwrap and/or theoverwrap hollow structure. The overwrap may enrobe the pessary device bymoving the pessary device along the longitudinal axis of the overwraphollow structure. The overwrap may enrobe the pessary device by movingthe overwrap hollow structure along the longitudinal axis of the pessarydevice.

The overwrap may exceed the enrobed pessary device at either end in thelongitudinal direction from about 0.5 mm to about 100 mm to form anoverwrap excess. The overwrap may exceed the enrobed pessary device inthe transverse axis by about 1 mm to 200 mm from the exterior surface.

The overwrap excess may be bunched together to form one or more bundles.The bundle may be formed by any means commonly known including usingair, a pin, mechanical means, a vacuum, and/or combinations thereof. Theoverwrap excess and/or bundles may be positioned inside the pessarydevice interior. The overwrap excess and/or the bundle may be positionedinside the pessary device cavity using any means commonly known but notlimited to, heat, vacuum, air, adhesives, mechanical means and/orcombinations thereof. In an embodiment, more than one bundle may beplaced inside the pessary device interior.

Once placed inside the pessary device interior, the overwrap excess canbe maintained inside the pessary device interior. The overwrap excesscan be maintained inside the pessary device interior through the use offriction, the use of adhesives, the use of heat, the use of mechanicalmeans and/or combinations thereof.

The method of overwrapping the pessary device is shown in FIG. 1 as aflowchart 700. The method includes providing a pessary device having anouter wall, an interior, an external opening to the interior, and alongitudinal axis 710. The method further includes providing an overwraphaving a longitudinal axis, wherein the overwrap forms a hollowstructure 720. At least a portion of the pessary device is placed insidethe overwrap hollow structure, wherein the overwrap enrobes the pessarydevice and exceeds the pessary device along the longitudinal axis tocreate an overwrap excess 730. The step of placing at least a portion ofthe pessary device inside the overwrap hollow structure, wherein theoverwrap exceeds the pessary device along the longitudinal axis tocreate an overwrap excess may comprise moving the pessary device alongthe longitudinal axis of the hollow structure overwrap, wrapping theoverwrap sheet around the longitudinal axis of the pessary device,and/or inverting the overwrap hollow structure as the overwrap movesalong the longitudinal axis of the pessary device. Moving the pessarydevice, wrapping the overwrap sheet, and/or inverting the overwrap maybe done using at least one or more seams using friction, the use ofadhesives, the use of heat, the use of mechanical means, and/orcombinations thereof. The overwrap excess is positioned in the pessarydevice interior to provide the wrapped pessary device 740.

FIGS. 2A and 2B show a pessary device 10. The pessary device 10 includesan upper portion 20, a lower portion 30, a middle portion 40, a pressureregion 50 of the upper portion 20, a pressure region 60 of the lowerportion 30, a maximum diameter D₁, a minimum diameter D₂, a slope 80extending from the upper portion 20 to the middle portion 40, a slope 90from the middle portion 40 to the lower portion 30, a longitudinal axis(L) and a transverse axis (T). As shown in FIGS. 2A and 2B, the pessarydevice 10 can have a top 100 that includes a convex portion 110, a base120 that includes a convex portion 130, and sides 140 that includeconcave portions 150. The pessary device can be symmetric about thelongitudinal axis, including for example, wherein the base is circularand symmetric about the longitudinal axis. The pessary device caninclude a third diameter D₃ that is greater than minimum diameter D₂,and convex portion 110 can be aligned with maximum diameter D₁ toprovide pressure region 50, and convex portion 130 can be aligned withmaximum diameter D₁ to provide pressure region 60. In addition, concaveportion 150 can be aligned with minimum diameter D₂ to form flexileregion 160.

FIG. 3 shows a pessary device 10 take along line 3-3 of FIG. 2. Thepessary device 10 includes an upper portion 20, a lower portion 30, amiddle portion 40, a pressure region 50 of the upper portion 20, apressure region 60 of the lower portion 30, a maximum diameter D₁, aminimum diameter D₂, a slope 80 extending from the upper portion 20 tothe middle portion 40, a slope 90 from the middle portion 40 to thelower portion 30, and a longitudinal axis (L). As shown in FIG. 3, thepessary device 10 can have a top 100 that includes a convex portion 110,a base 120 that includes a convex portion 130, and sides 140 thatinclude concave portions 150. As shown in FIG. 3, the pessary device 10can have outer wall 250 and an interior 200 defined by inner walls 240that is hollow in region 220. The hollow region 220 can be provided atone or both ends. In addition, the pessary device 10 can have a portionof the interior 200 that is solid.

FIG. 4 shows a pessary device 10. The pessary device 10 includes anupper portion 20, a lower portion 30, a middle portion 40, a pressureregion 50 of the upper portion 20, a pressure region 60 of the lowerportion 30, a maximum diameter D₁, a minimum diameter D₂, a slope 80extending from the upper portion 20 to the middle portion 40, a slope 90from the middle portion 40 to the lower portion 30, and a longitudinalaxis (L) crossing both ends. As shown in FIG. 4, the pessary device 10can have a top 100 that includes a convex portion 110, a base 120 thatincludes a convex portion 130, and sides 140 that include concaveportions 150. As shown in FIG. 4, the pessary device 10 can have aninterior 200 that is hollow. The pessary device has inner walls 240 thatdefine interior 200 and hollow region 220. In addition, the inner walls240 can have the same or a similar profile as the outer walls 250.

FIG. 5 shows a pessary device 10. The pessary device 10 includes anupper portion 20, a lower portion 30, a middle portion 40, a pressureregion 50 of the upper portion 20, a pressure region 60 of the lowerportion 30, a maximum diameter D₁, a minimum diameter D₂, a slope 80extending from the upper portion 20 to the middle portion 40, a slope 90from the middle portion 40 to the lower portion 30, and a longitudinalaxis (L) crossing both ends. As shown in FIG. 5, the pessary device 10can have a top 100 that includes a convex portion 110, a base 120 thatincludes a convex portion 130, and sides 140 that include concaveportions 150. As shown in FIG. 5, the pessary device 10 has an interior200 that is hollow. The pessary device has inner walls 240 that defineinterior 200 and hollow region 220. The hollow region 220 can have afirst profile defined by inner walls 240 and a different profile definedby outer walls 250, such as, for example, where the hollow region 220 isin the form of a tube.

FIG. 6 shows a pessary device 10. The pessary device 10 includes anupper portion 20, a lower portion 30, a middle portion 40, a pressureregion 50 of the upper portion 20, a pressure region 60 of the lowerportion 30, a slope 80 extending from the upper portion 20 to the middleportion 40, a slope 90 from the middle portion 40 to the lower portion30, and a longitudinal axis (L). As shown in FIG. 6, the pessary device10 can have a top 100 that includes a convex portion 110, a base 120that includes a convex portion 130, and sides 140 that include concaveportions 150. The pessary device can also have a flexile region 160. Thepessary device 10 can have an interior 200 that is hollow. In addition,as shown in FIG. 6, the pessary device 10 can have an opening 170 on oneor more of top 100 and/or on base 120.

The pessary device 10 can include an overwrap 300 and/or a withdrawalmember 310, such as, for example, as shown in FIG. 7. In addition, FIG.7 shows that withdrawal member 310 can be attached to overwrap 300.

FIG. 8 shows a pessary device 10 on an overwrap 300. The overwrap 300has a longitudinal axis 540. The overwrap 300 may exceed the pessarydevice 10 at either end 252, 254 along the overwrap longitudinal axis540.

FIG. 9 shows a pessary device 10 located inside an overwrap 300. Theoverwrap 300 forms a hollow structure 560 containing the pessary device10. The overwrap 300 covers the pessary device and exceeds it along thelongitudinal axis of the pessary device 10 to form an overwrap excess330. The overwrap excess 330 is bunched to form a bundle 320.

FIG. 10 shows a pessary device 10 located inside an overwrap 300,specifically, the overwrap hollow structure 540. The overwrap 300 coversthe pessary device and exceeds it along the longitudinal axis of thepessary device 10. The bundles 320 are inside the hollow region 220 ofthe pessary device 10.

FIG. 11A-D show examples of external opening to the interior engagingmembers. The engaging members can be triangles 610, half circles 620,quarter circles 630, and/or geometric shapes with points 640. Theengaging members can engage with the overwrap.

The pessary device can be inserted in any suitable manner, such as, forexample, using an applicator. FIG. 12 shows an applicator 410 thatincludes an insertion member 420 and a plunger 440. The insertion member420 has an insertion end 421 and a withdrawal end 422 opposite theinsertion end 421. The insertion member 420 also can include a barrelregion 450 adapted to contain a pessary device, and a grip region 430that can be an indentation region 424 provided opposite the insertionend 421, such as, e.g., proximal to the withdrawal end 422. The gripregion 430 can include one or more grip elements 423.

Generally, the pessary device does not change in size during the usageexperience, that is, the pessary device is the same size and diameterprior to insertion by the user as well as during use and removal. Forexample, the pessary device is not expandable or inflatable from itsoriginal size and the pessary device is not compressed for insertioninto the user's body, nor is the pessary device compressed forwithdrawal from the user's body. A portion or region of the pessarydevice can flex or be deformed, such as, for example, in the regionhaving the minimum diameter, but the pessary device does not expand andreturns to the original configuration after deformation. As such, thepessary device does not include any mechanical or other means thatrequires the user to change the size or shape of the pessary deviceduring use, such as, for example, before or after insertion or prior towithdrawal. This provides for a pessary device that has a size uponwithdrawal that is the same as the size during use, which can providefor improved comfort during use and withdrawal.

The pessary device can have a pressure region that has the maximumdiameter of the pessary, such as, for example, at the base or at thetop, that extends between the anterior vaginal wall and the posteriorvaginal wall of a consumer to provide pressure on the urethra throughthe vaginal wall. In addition, the pessary device can have a secondpressure region having an increased diameter as compared to the minimumdiameter that can provide pressure on the urethra through the vaginalwall at a point apart from the first pressure region. The first pressureregion and the second pressure region can be separated by any suitabledistance, such as, for example, by at least about 5 mm, at least about10 mm, at least about 15 mm, at least about 20 mm, at least about 25 mm,at least about 30 mm, at least about 35 mm, at least about 40 mm, atleast about 45 mm, at least about 50 mm, or any other suitable distance.

The pessary device can have any suitable number of pressure regions,including for example, two pressure regions, such as, for example, fouror fewer pressure regions, three or fewer pressure regions, two or fewerpressure regions, one pressure region, or any other suitable number ofpressure regions.

The pressure region or regions can be any suitable shape, such as, forexample, a convex shape that provides pressure to the vaginal wall,including, for example, a lobe or other protuberance. The pressureregion or regions can have a substantially circular cross-section. Thepessary device also can include a minimum diameter region that is aflexile region that can provide flexibility to the pessary device, suchas, for example, by allowing bending or movement at the flexile region.The flexile region can be any suitable shape, such as, for example,concave, indented, or the like, and can have any suitable cross-section,such as, for example, a substantially circular cross-section. Thepessary device can include a flexile region provided between twopressure regions.

Maximum pressure to the urethra and maximum urethral closure can bemeasured using any suitable method, such as, for example, by using thecomputational model described in U.S. Patent Appin. No. 2007/0027667.For example, a computation model simulating the human internal pelvicenvironment can be used. In certain embodiments, thirteen nodes on theurethra in the simulation that are both on the back wall toward thevagina and in the middle of the body on the sagittal plane can bechosen. The points should be spread even along the length of the urethrawith the first point at the bottom edge of the urethra and the lastpoint at the bladder neck. Node vs. time vs. Von Mises stress should beobtained using a suitable software program, such as, for example,LS-Prepost, for all chosen nodes. The data columns are then matched todetermine the y position vs. time vs. Von Mises stress. Generally, onlythe data that is at the simulation end point should be selected andy-position vs. Von Mises is then plotted.

The flexile region, on the other hand, is more flexible than andprovides less resistance than the pressure region. Addition of theflexile region can allow the pessary device to flex in the longitudinaldirection as well at the lateral direction. For example, the pessarydevice can compress more than about 1 cm when measured under 0.5 psiwhen the force is applied from the top to the base along thelongitudinal axis. In addition, or alternatively, the flexile region canprovide a bending region that facilitates the pessary device bendingfrom side to side.

The pessary device can be a unitary construction. For example, thepessary device can include a continuous outer shell that defines theentire exterior surface of the pessary device. The outer shell can besmooth or textured. The outer shell may be permeable to fluid, such as,for example, by the inclusion of holes, pores, or other suitableexternal openings. Alternatively, the outer shell can be impermeable tofluid such that fluid cannot enter the device. In addition, the pessarydevice can include an external opening in the top and/or base. Thepessary device can include an external opening in the top and/or baseand the outer shell is not permeable to fluid such that fluid cannotenter the device except through the external opening in the top and/orbase.

The opening may be of any suitable dimension, such as, for example, anarea of about 0.01 mm² to about 900 mm², an area of about 0.1 mm² toabout 500 mm², an area of about 1 mm² to about 350 mm², an area of about5 mm² to about 100 mm², an area of about 10 mm² to about 100 mm², anarea of about 15 mm² to about 50 mm², or an area of about 20 mm² toabout 30 mm².

The opening to the interior may have external opening to the interiorengaging members. The engaging members can be triangles, half circles,quarter circles, and/or geometric shapes with points. The engagingmembers can engage with the overwrap.

Suitable pessary devices can be solid or can have a hollow interior orcavity. For hollow devices, the pessary device can have an outerperiphery defining a total area of the device and an inner peripherydefining an open area of the device. The open area can be any suitablesize, such as, for example, between about 5% to about 95% of the totalarea, such as, for example, from about 10% to about 90% of the totalarea, from about 15% to about 85% of the total area, or from about 20%to about 80% of the total area. In addition, the pessary device also canhave a wall thickness that is suitable to maintain the pessaryconfiguration. The wall thickness can be greater than about 0.5 mm, suchas, for example, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5mm, or greater. The wall thickness can be constant or varied along thelength of the pessary device and/or around the circumference of thepessary device.

The pessary device can have any suitable shape having a varied diameteralong the longitudinal axis, such as, for example, a shape having avaried diameter that is symmetrical with respect to the longitudinalaxis, such as, for example, a teardrop, an apple, a pear, an hourglass,a waisted cylinder, a figure-8 shape, a peanut shape, a heart-shape, alight bulb shape, a bottle shape, a vase shape, or any other suitableshape. In addition, the shape can have a varied diameter and can besymmetrical with respect to both the longitudinal and lateral axis, suchas, for example, an hourglass, a waisted cylinder, a figure-8 shape, apeanut shape, or any other suitable shape. Alternatively, the pessarydevice can have an asymmetrical shape, such as, for example, a B-shapeor a P-shape. The pessary device can be symmetrical at one region andasymmetrical at another region, such as, for example, where the pessarydevice has a symmetrical pressure region and an asymmetrical flexileregion. Generally, the pessary device can have a varying diameter thatcan provide varying pressure along the user's urethra. For example, thepessary device can have a convex portion that can correspond to thepressure region. In addition, the pessary device can have a minimumdiameter region that can be a concave region. The concave region cancorrespond to the flexile region.

The pessary device can be hourglass shaped. For example, as shown inFIG. 2, the pessary device can have upper and lower portions joinedtogether by a waistline portion, with the upper and lower portionshaving diameters that are both greater than a diameter of the waistlineportion such that the pessary device has a generally hourglassconfiguration. In this configuration, the upper portion of the pessarydevice can have a top and the lower portion of the pessary device canhave a base, and the pessary device can have sloping upper and lowerwall sections joining the top and the base with the waistline portion.In addition, the waistline portion can include the minimum diameter ofthe pessary device. The upper and lower portions can have generallycoequal maximum diameters, or the upper and lower portions can havedifferent maximum diameters, such as, for example, where the upperportion has a maximum diameter greater than the lower portion or wherethe lower portion has a maximum diameter greater than the upper portion.

Generally, the pessary device includes at least one maximum diameter andat least one minimum diameter, where the minimum diameter is smallerthan the maximum diameter. The pessary device can include a firstportion having a maximum diameter, a second portion having a maximumdiameter, and a third portion that has a minimum diameter. The maximumdiameter of the first portion and the maximum diameter of the secondportion can be separated by a distance that is greater than about 10% ofthe length of the pessary device, such as, for example, by a distancegreater than about 5 mm, greater than about 10 mm, greater than about 15mm, greater than about 20 mm, greater than about 25 mm, greater thanabout 30 mm, greater than about 35 mm, greater than about 40 mm, greaterthan about 45 mm, or more. The pessary device can provide pressure atmid-urethra, the bladder neck, or both. In addition, the pessary devicecan provide higher pressure at the mid-urethra, the bladder neck, orboth and provides lower pressure at the area between the mid-urethra andthe bladder neck. For example, the pressure region can provide pressureat levels about 25% higher than the pressure provided by the flexileregion, such as, for example, at levels about 30% higher, about 35%higher, about 40% higher, about 45% higher, about 50% higher, about 55%higher, about 60% higher, or more.

The pessary device can have a slope from the maximum diameter to theminimum diameter. Any suitable slope can be used, including for example,about 0.25 mm, about 0.5 mm, about 0.75 mm, about 1 mm, about 1.5 mm,about 2 mm, about 2.5 mm, about 3 mm, about 4 mm, about 5 mm, about 6mm, about 7 mm, about 8 mm, or more, such as, for example, a slope fromabout 0.25 mm to about 5 mm, or a slope from about 0 5 mm to about 4 mm,or any other suitable range.

Suitable pessary devices are typically smaller in size than conventionalpessary devices. For example, the pessary devices have a maximumdiameter, a length, and/or a volume that is smaller or less than that ofconventional pessary devices.

The pessary devices can have any suitable maximum diameter, such as, forexample, a maximum diameter of less than 35 mm, such as, for example,less than 34 mm, less than 33 mm, less than 32 mm, less than 31 mm, lessthan 30 mm, less than 29 mm, less than 28 mm, less than 27 mm, less than26 mm, less than 25 mm, less than 24 mm, less than 23 mm, less than 22mm, less than 21 mm, less than 20 mm, less than 19 mm, less than 18 mm,less than 17 mm, less than 16 mm, less than 15 mm, less than 14 mm, lessthan 13 mm, less than 12 mm, less than 11 mm, or less than 10 mm,including, for example, a maximum diameter of from about 10 mm to about35 mm, from about 10 mm to about 25 mm, from about 13 mm to about 25 mm,or from about 15 mm to about 22 mm The maximum diameter or width istypically measured at the widest portion of the pessary devicesubstantially perpendicular to the longitudinal axis.

The pessary devices can have any suitable minimum diameter that issmaller than the maximum diameter, including, for example, a minimumdiameter from about 40% to about 95% of the maximum diameter, from about40% to about 90% of the maximum diameter, from about 40% to about 85% ofthe maximum diameter, from about 40% to about 80% of the maximumdiameter, from about 45% to about 75% of the maximum diameter, or fromabout 50% to about 70% of the maximum diameter, such as, for example,about 45% of the maximum diameter, about 50% of the maximum diameter,about 55% of the maximum diameter, about 60% of the maximum diameter,about 65% of the maximum diameter, or about 70% of the maximum diameter.

The pessary devices can have a minimum diameter from about 4 mm to about28 mm, about 5 mm to about 20 mm, about 8 mm to about 20 mm, from about8 mm to about 18 mm, or from about 8 mm to about 15 mm, such as, forexample, about 8 mm, about 8.5 mm, about 9 mm, about 9.5 mm, about 10mm, about 10.5 mm, about 11 mm, about 11 5 mm, about 12 mm, about 12.5mm, about 13 mm, about 13.5 mm, about 14 mm, about 14 5 mm, about 15 mm,about 15.5 mm, about 16 mm, about 16.5 mm, about 17 mm, about 17 5 mm,about 18 mm, about 18.5 mm, about 19 mm, about 19.5 mm, or about 20 mm,or any other suitable minimum diameter. The minimum diameter or width istypically measured at the narrowest portion of the pessary devicesubstantially perpendicular to the longitudinal axis.

The maximum diameter and the minimum diameter can be separated by anysuitable distance, such as, for example, by about 5 mm, about 10 mm,about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about40 mm, about 45 mm, about 50 mm, or any other suitable distance.

The pessary devices can have any suitable length, such as, for example,a length from about 35 mm to about 60 mm, about 40 mm to about 55 mm, orabout 40 mm to about 50 mm, such as, for example, a length about 35 mm,about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm,about 47 mm, about 48 mm, about 49 mm, or about 50 mm The length istypically measured substantially parallel to the longitudinal axis ofthe pessary device.

Generally, the pessary device can have a weight of less than about 10grams, less than about 9 grams, less than about 8 grams, less than about7 grams, less than about 6 grams, less than about 5 grams, less thanabout 4 grams, less than about 3 grams, less than about 2 grams, orabout 1 gram, including for example, a weight of from about 1 gram toabout 7 grams, or from about 2 grams to about 6 grams, or from about 3grams to about 5 grams.

Pessary devices can be fabricated using any suitable materials andmethods. For example, pessaries can be formed from polymeric materials,such as, for example, polycarbonate, polyester, polyethylene,polyacrylamide, polyformaldehyde, polymethylmethacrylate, polypropylene,polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride,polyurethane, nylon, silicone, or mixtures or blends thereof, ormetallic materials.

Pessary devices can be formed in any suitable manner, such as, forexample, using injection molding or other suitable methods of formingthe pessary device.

The pessary device is covered by an overwrap. The overwrap can benon-absorbent or absorbent and can include any suitable material, suchas, for example, a fibrous nonwoven material comprising natural,synthetic, or a blend of natural and synthetic fibers. Suitablesynthetic fibers can include, e.g., fibers such as polyester,polyolefin, nylon, polypropylene, polyethylene, polyacrylic, celluloseacetate, polyhydroxyalkanoates, aliphatic ester polycondensates,bicomponent fibers and/or mixtures thereof. Natural fibers can include,e.g., rayon and those commonly known to be non-synthetic and of naturalorigin such as cotton. The fibers can have any suitable cross-sectionalshape, such as, e.g., round, tri-lobal, multi-lobal, delta, hollow,ribbon-shaped, and/or any other suitable shape, or mixtures thereof.Fibers with any suitable diameter can be used, such as, e.g., from about0.5 to about 50 microns, such as, e.g., from about 1 to about 30microns, such as, e.g., from about 10 to about 25 microns. Fiberdiameter can be determined using any suitable means; however, fornon-round fibers, diameter can typically be determined by reference tothe diameter of a fiber with the same cross-sectional area as thenon-round fiber.

The overwrap can be made by any number of suitable techniques and canhave any suitable basis weight. Suitable techniques include, forexample, carding, meltblowing, spunbonding, spunlacing, air laying, andthe like. For example, the overwrap can be formed using bonding methods,such as, e.g., thermal, ultrasonic, resin, through-air bonding,hydroentangling, and/or needling. The basis weight of the overwrap canbe any suitable weight, such as, e.g., from about 10 to about 60 gramsper square meter (gsm), such as, e.g., from about 15 to about 30 gsm. Inaddition, the overwrap can be hydrophilic or hydrophobic. The overwrapmay be elastic. The overwrap may be shrinkable when exposed to heat orinfrared. The overwrap can be joined to the pessary device by anyvariety of means. The overwrap can be joined to itself or to the pessarydevice. For example, one portion of overwrap can be joined to an opposedportion of the overwrap or to the pessary device using any suitableadhesive, heat, vacuum, air, pressure bonding, and/or mechanical means.Such adhesive can extend continuously along the length of attachment orit can be applied in a non-continuous fashion at discrete intervals.Heat bonding includes thermally bonding, fusion bonding, or any othersuitable means for joining such materials. The overwrap can be joined toitself to form a hollow structure. The hollow structure may be in theform of any multi-dimensional geometric structure such as, for example,a cylinder, tunnel, tube, cube, and/or a pyramid.

At least a portion of the pessary device may be placed inside theoverwrap hollow structure. The overwrap hollow structure may enrobe thepessary device. The overwrap can enrobe the pessary device by wrappingthe pessary device along the longitudinal axis of the pessary device.The overwrap may enrobe the pessary device by rolling the pessary devicealong the longitudinal axis when placed inside the overwrap hollowstructure. The overwrap may enrobe the pessary device by moving thepessary device along the longitudinal axis of the overwrap hollowstructure. The overwrap may enrobe the pessary device by moving theoverwrap hollow structure along the longitudinal axis of the pessarydevice.

The overwrap hollow structure may exceed the pessary device at eitherend in the longitudinal direction from about 0.5 mm to about 100 mm toform an overwrap excess, such as, for example, by about 0.5 mm, about 1mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm,about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, about6.5 mm, about 7 mm, about 7.5 mm, about 8 mm, about 8.5 mm, about 9 mm,about 9 5 mm, about 10 mm, about 10.5 mm, about 11 mm, about 11.5 mm,about 12 mm, about 12.5 mm, about 13 mm, about 13.5 mm, about 14 mm,about 14.5 mm, about 15 mm, about 15.5 mm, about 16 mm, about 16.5 mm,about 17 mm, about 17.5 mm, about 18 mm, about 18.5 mm, about 19 mm,about 19.5 mm, or about 20 mm, about 20.5 mm, about 21 mm, about 21.5mm, about 22 mm, about 22.5 mm, about 23 mm, about 23.5 mm, about 24 mm,about 24.5 mm, about 25 mm, about 30 mm, about 40 mm, about 50 mm, about60 mm, about 70 mm, about 80 mm, about 90 mm, and up to 100 mm Theoverwrap hollow structure may exceed the pessary device in thetransverse axis by about 1 mm to 200 mm from the exterior surface, suchas, for example 1 mm, 10 mm, 20 mm, 30 mm, 40 mm, 50 mm, 60 mm, 70 mm,80 mm, 90 mm, 100 mm.

The overwrap excess may be bunched together to form one or more bundles.The bundle may be formed by any means commonly known including usingair, a pin, mechanical means, a vacuum, and/or combinations thereof. Theoverwrap hollow structure excess bundles may be positioned inside thepessary device interior. The overwrap excess and/or the bundle may bepositioned inside the pessary device cavity using any means commonlyknown but not limited to, heat, vacuum, air, adhesives, mechanical meansand/or combinations thereof. In an embodiment, more than one bundle maybe placed inside the pessary device interior.

Once placed inside the pessary device interior, the bundle can bemaintained inside the pessary device interior. The bundle can bemaintained inside the pessary device interior through the use offriction, the use of adhesives, the use of heat, the use of mechanicalmeans and/or combinations thereof.

The overwrap may be manipulated to conform to the pessary device.Manipulation of the overwrap may occur using one or more strands aroundthe transverse and/or longitudinal axis of the pessary device. Thestrands may be tied to the pessary device. The strands may be sewn tothe overwrap and/or pessary device.

The overwrap may be manipulated while covering the pessary device byanchoring at least one of the ends of the overwrap and manipulating theoverwrap by rotating the device along the longitudinal axis. Theoverwrap may be anchored by friction, the use of adhesives, the use ofheat, and/or combinations thereof.

The overwrap may be manipulated by stretching the overwrap hollowstructure enrobing the pessary device and allowing it to contract to theshape of the pessary device. The overwrap may be manipulated to deformthe overwrap hollow structure to match the shape of the enrobed pessarydevice. Manipulation of the overwrap may occur by any means commonlyknown, such as, mechanical means, force, heat, infrared, microwave,radar, ultrasound, steam, chemical reactions, and/or combinationsthereof.

The overwrap may be manipulated to conform to the pessary device bycreating one or more attachment points. The attachment points may becreated by heat and/or adhesives. The attachment points may be locatedat any portion of the pessary device including the ends, along thelongitudinal axis, and along a transverse axis. The attachment pointsmay form quadrants, triangles, or any other known pattern.

The pessary device can include a withdrawal member that can comprise anysuitable material, including for example, cotton, cellulose, rayon,polyolefins such as, for example, polyethylene or polypropylene, nylon,silk, polytetrafluoroethylene, Teflon, wax, or any other suitablematerials.

The withdrawal member can be formed by any suitable formation method andin any suitable configuration, such as, e.g., one or more cords,strings, finger covers, ribbons, an extension of a material of thedevice, or combinations thereof.

The pessary device can be inserted without the use of an applicator. Thepessary device can be inserted digitally using one or more of the user'sfingers.

The pessary device can be inserted using an applicator that can includean insertion member and a plunger. The insertion member can have aninsertion end and a withdrawal end opposite the insertion end. Theinsertion member also can include a barrel region adapted to contain thepessary device, and a grip region that can be an indentation regionprovided opposite the insertion end, such as, e.g., proximal to thewithdrawal end.

The insertion member and/or plunger can be constructed from any suitablematerial. Suitable materials include, for example, paper, paperboard,cardboard, cellulose, such as, e.g., molded cellulose, or anycombinations thereof, polyethylene, polypropylene, polybutylene,polystyrene, polyvinylchloride, polyacrylate, polymethacrylate,polyacrylonitrile, polyacrylamide, polyamide, nylon, polyimide,polyester, polycarbonate, polylactic acid, poly hydroxyalkanoate,ethylene vinyl acetate, polyurethane, silicone, derivatives thereof,copolymers thereof, mixtures thereof, or any suitable smooth plasticmaterial. Examples of suitable materials are disclosed in, e.g., U.S.Pat. Nos. 5,346,468 and 5,558,631. Additives can be included in thematerial to alter or enhance certain material properties. Suitableadditives include, for example, mold release agents, slip agents,surface energy modifiers, pearlescent agents, and/or any other suitableadditives. The insertion member also or alternatively can be coated witha substance to give it a high slip characteristic, such as, e.g., withwax, polyethylene, a combination of wax and polyethylene, cellophane,clay, mica, and other lubricants that can facilitate comfortableinsertion. Alternatively, or in addition, the insertion member caninclude a textured surface. Texture can be provided in any suitablemanner, such as, e.g., by designing texture into or adding texture tothe insertion member.

The insertion member can include a grip region, such as, for example, anindentation region. The grip region can have a plurality ofthree-dimensional surface elements, such as, e.g., projections, rings,ridges, ribs, embossments, depressions, grooves, and/or other grippingstructures. The three-dimensional surface elements can be provided inany suitable manner, such as, e.g., by the addition of material, and/orby impressing, such as, e.g., by embossing, or compressing the surfaces.For example, the indentation region can include one or more flattenedsides and/or one or more spaces for a decorative marking or a character,such as, e.g., an embossed and/or printed marking or character. Inaddition, or alternatively, the surfaces of the indentation region caninclude a material that can provide a frictional resistance for theuser's fingers during the insertion of the applicator into the body.Suitable materials that can provide friction include, for example,abrasive materials, high wet coefficient of friction materials, pressuresensitive adhesives, or any combinations thereof.

The pessary device can be used daily. For example a user can insert thepessary device, wear the pessary device for a suitable wear time, suchas, for example, up to 4 hours, up to 5 hours, up to 6 hours, up to 7hours, up to 8 hours, up to 9 hours, up to 10 hours, up to 11 hours, upto 12 hours, or up to 16 hours, or more, remove the pessary device,dispose of the pessary device, and insert a new pessary device.

The dimensions and values disclosed herein are not to be understood asbeing strictly limited to the exact numerical values recited. Instead,unless otherwise specified, each such dimension is intended to mean boththe recited value and a functionally equivalent range surrounding thatvalue. For example, a dimension disclosed as “40 mm” is intended to mean“about 40 mm.”

All documents cited in the Detailed Description of the Invention are, inrelevant part, incorporated herein by reference; the citation of anydocument is not to be construed as an admission that it is prior artwith respect to the present invention. To the extent that any meaning ordefinition of a term in this document conflicts with any meaning ordefinition of the same term in a document incorporated by reference, themeaning or definition assigned to that term in this document shallgovern.

While particular embodiments of the present invention have beenillustrated and described, it would be obvious to those skilled in theart that various other changes and modifications can be made withoutdeparting from the spirit and scope of the invention. It is thereforeintended to cover in the appended claims all such changes andmodifications that are within the scope of this invention.

What is claimed is:
 1. A pessary device comprising an outer wall, aninterior, an external opening to the interior, and one or more externalopening to the interior engaging members.
 2. The pessary device of claim1, wherein the external opening to the interior engaging memberscomprise of triangles, half circles, quarter circles, and/or geometricshapes with points.
 3. The pessary device of claim 1, wherein thepessary device external opening comprises an area of about 0.01 mm² toabout 900 mm².
 4. The pessary device of claim 1, wherein the pessarydevice further comprises an overwrap.
 5. The pessary device of claim 4,wherein the outer wall has an inner surface and an outer surface,wherein the overwrap contacts the entire outer wall outer surface. 6.The pessary device of claim 4, wherein the pessary device is disposedwithin an applicator, wherein the applicator comprises a barrel regionand a grip region.
 7. The pessary device of claim 6, wherein theapplicator grip region comprises a grip element selected from the groupcomprising projections, rings, ridges, ribs, embossments, depressions,grooves, and/or other gripping structures.
 8. The pessary device ofclaim 1, wherein the pessary device further comprises a top, a base, anda length.
 9. The pessary device of claim 8, wherein the pessary devicetop comprises a pressure region and wherein the pessary device bottomcomprises a pressure region.
 10. The pessary device of claim 4, whereinthe external opening to the interior engaging members engage with theoverwrap.
 11. A pessary product, comprising: a. An applicator comprisinga barrel region and a grip region; and b. A pessary device disposedwithin the barrel region, the pessary device comprising an outer wall,an interior, an external opening to the interior, and one or moreexternal opening to the interior engaging members.
 12. The pessarydevice of claim 11, wherein the external opening to the interiorengaging members comprise of triangles, half circles, quarter circles,and/or geometric shapes with points.
 13. The pessary device of claim 11,wherein the pessary device external opening comprises an area of about0.01 mm² to about 900 mm².
 14. The pessary device of claim 11, whereinthe pessary device further comprises an overwrap.
 15. The pessary deviceof claim 14, wherein the outer wall has an inner surface and an outersurface, wherein the overwrap contacts the entire outer wall outersurface.
 16. The pessary product of claim 11, wherein the applicatorgrip region comprises a grip element selected from the group comprisingprojections, rings, ridges, ribs, embossments, depressions, grooves,and/or other gripping structures.
 17. The pessary device of claim 11,wherein the pessary device further comprises a top, a base, and alength.
 18. The pessary device of claim 17, wherein the pessary devicetop comprises a pressure region and wherein the pessary device bottomcomprises a pressure region.
 19. The pessary device of claim 14, whereinthe external opening to the interior engaging members engage with theoverwrap.